China Aoxing Pharmaceutical Company Announces Submission of NDA of Its Leading Narcotic Drug for the Treatment of Acute Moderate
03 September 2009 - 10:00PM
Marketwired
China Aoxing Pharmaceutical Company, Inc. (OTCBB: CAXG) ("China
Aoxing"), a pharmaceutical company specializing in research,
development, manufacturing and marketing of narcotic and
pain-management products, today announced that it has submitted a
new drug application (NDA) to the China State Food and Drug
Administration (SFDA) for its Codeine Phosphate, a compound oral
solution for the treatment of acute moderate to severe cough.
Under the regulation of the China SFDA, this drug is designated
as a Class III New Medicine, or the first drug to be launched in
China while already selling in other regulated territories. As a
result, the product is expected to receive at least three-year
market exclusivity protection after marketing clearance by the
China SFDA. In June 2009, China Aoxing announced that it had
completed the clinical studies required for an NDA by the China
SFDA. Assuming timely regulatory approval, the company expects to
launch this product in China in 2010. China Aoxing believes that
this product will give physicians a more effective option to the
conventional drugs for the treatment of acute moderate to severe
cough in China.
"This is a major achievement of our company. We believe that
this drug will address a growing and presently unserved need in the
marketplace, and we are very hopeful that the SFDA will find our
submission acceptable for final production approval. We believe
that we have adhered to the requirements we agreed upon with the
SFDA at our pre-NDA meeting. We are also very pleased with the
tremendous team effort, great planning and execution by our own
staff," said Zhenjiang Yue, the Chairman and the CEO of China
Aoxing.
The prevalence rate of cough condition is approximately at 15%
in China. It is estimated that over 50 million Chinese patients are
seeking cough treatment, mainly caused by respiratory disorders.
The market size of pharmaceutical product to address cough
condition is estimated approximately $2 billion per year with an
annual growth rate of over 10% in China.
About China Aoxing Pharmaceutical Company, Inc.
China Aoxing Pharmaceutical Company, Inc. (OTCBB: CAXG) is a
pharmaceutical company located in China specializing in research,
development, manufacturing and distribution of a variety of
narcotics and pain-management products. It has a strategic alliance
with American Oriental Bioengineering, Inc. (NYSE: AOB) to develop
and market various narcotic drugs in China. Headquartered in
Shijiazhuang City, the pharmaceutical capital of China, outside of
Beijing, China Aoxing has China's largest and the most advanced
manufacturing facility for highly regulated narcotic medicines,
addressing a very under-served and fast-growing market in China.
Its facility is one of the few GMP facilities licensed for
narcotics medicines. The Company is working closely with the
Chinese government and SFDA to assure the strictly regulated
availability to medical professionals of its narcotic drugs and
pain medicines throughout China.
Statements made in this press release are forward-looking and
are made pursuant to the safe harbor provisions of the Securities
Litigation Reform Act of 1995. Such statements involve risks and
uncertainties that may cause actual results to differ materially
from those set forth in these statements. The economic,
competitive, governmental, technological and other risk factors
identified in the Company's filings with the Securities and
Exchange Commission, including the Form 10-KSB for the year ended
June 30, 2008, may cause actual results or events to differ
materially from those described in the forward-looking statements
in this press release. The Company undertakes no obligation to
publicly update or revise any forward-looking statements, whether
because of new information, future events, or otherwise.
Contact: Wei Zhang China Aoxing Pharmaceutical Company, Inc.
Email: chinaaoxing@gmail.com Telephone: 646 - 367-1747 Website:
www.chinapainmed.com
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